VidPrevtyn Beta

Medicinal product

(Invented) name

VidPrevtyn Beta

Active substance (s)

COVID-19 vakcina (rekombinantinė, adjuvantinė). SARS-CoV-2 spyglio baltymas (B.1.351 padermė)

Strength

5 µg/dozėje

Pharmaceutical form

tirpalas ir emulsija injekcinei emulsijai

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BX03, Covid-19 vaccines

Marketing authorisation holder

Sanofi Pasteur, Prancūzija

Date of authorisation

2022-11-10

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution and emulsion for emulsion for injection. After mixing, one dose (0,5 mL) contains	0.5 ml
COVID-19 vakcina (rekombinantinė, adjuvantinė). SARS-CoV-2 spyglio baltymas (B.1.351 padermė)	5 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
109826	95933	1095933	flakonas	N10 (antigenas) + N10 (adjuvantas) (daugiadozis, 100 dozių)		Receptinis	EU/1/21/1580/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-03-18	Išregistruotas
2022-11-10	Registruotas